At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 304 enrolled
Drug / intervention
eszopiclone +1 moredrug
Likely dose
eszopiclone 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long Term, Open-Label, Safety Study of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
In Brief
A Phase 3 clinical trial evaluating eszopiclone for Insomnia and Attention Deficit Hyperactivity Disorder. Completed, enrolled 304 participants across 89 sites.
Detailed Summary
A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Attention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartMay 2009
Primary CompletionOct 2011
TodayJul 2026
First PostedMar 6, 2009
Enrollment StartMay 1, 2009
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.3 years ago
Interventions
eszopiclonedrug
One 2 mg tablet per day for 12 months
eszopiclonedrug
one 3mg tablet per day for 12 months